Designation granted for inves­ti­ga­tional agent elotuzumab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for treat­ment of mul­ti­ple myeloma in patients who have re­ceived one or more prior ther­a­pies

Princeton, NJ and North Chicago, IL (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted elotuzumab, an inves­ti­ga­tional humanized mono­clonal anti­body, Break­through Therapy Desig­na­tion for use in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of mul­ti­ple myeloma in patients who have re­ceived one or more prior ther­a­pies. The desig­na­tion is based on findings from a ran­dom­ized Phase 2, open-label study that eval­u­ated two dose levels of elotuzumab in com­bi­na­tion with lena­lido­mide and low-dose dexa­meth­a­sone in pre­vi­ously-treated patients, in­­clud­ing the 10 mg/kg dose that is being studied in Phase 3 trials. Data from the Phase 2 trial were most recently pre­sented at the 18th Annual Congress of the Euro­pean He­ma­tol­ogy Asso­ci­a­tion (EHA) in 2013 (click here to view press re­lease).

According to the FDA, Break­through Therapy Desig­na­tion is in­tended to expedite the devel­op­ment and review of drugs for serious or life-threatening con­di­tions. The criteria for Break­through Therapy Desig­na­tion re­quire pre­lim­i­nary clin­i­cal evi­dence that dem­onstrates the drug may have sub­stan­tial im­prove­ment on at least one clin­i­cally sig­nif­i­cant end­point over avail­able ther­apy.

“Despite recent ad­vances in the treat­ment of re­lapsed or re­frac­tory mul­ti­ple myeloma, it remains an area of unmet need,” said Michael Giordano, senior vice pres­i­dent, Head of De­vel­op­ment, Oncology & Immuno­sciences, Bristol-Myers Squibb. “This Break­through Therapy Desig­na­tion underscores the poten­tial of elotuzumab in this setting and reinforces Bristol-Myers Squibb’s longstanding com­mitment to the re­search and devel­op­ment of novel med­i­cines to treat hema­to­logic malig­nan­cies.”

About Elotuzumab

Elotuzumab is a humanized IgG1 mono­clonal anti­body targeted against Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein ex­pressed on myeloma and Natural Killer cells but not detectable in nor­mal tissue. The com­pany is investigating whether through both direct activation and engagement of Natural Killer cells, elotuzumab may sel­ectively target and kill SLAMF7 expressing myeloma cells.

Elotuzumab is being studied as a mono­therapy in smol­der­ing myeloma and in com­bi­na­tion with other ther­a­pies in first-line and re­lapsed or re­frac­tory mul­ti­ple myeloma. A clin­i­cal devel­op­ment pro­gram for the agent is underway, in­­clud­ing Phase 3 trials in first-line mul­ti­ple myeloma (ELOQUENT-1) and re­lapsed or re­frac­tory mul­ti­ple myeloma (ELOQUENT-2). Elotuzumab is also being in­ves­ti­gated in a ran­dom­ized Phase 2 study of bor­tez­o­mib and dexa­meth­a­sone in re­lapsed or re­frac­tory mul­ti­ple myeloma.

Elotuzumab is being co-developed with AbbVie, with Bristol-Myers Squibb lead­ing the com­mer­cial­iza­tion of the agent.

About Multiple Myeloma

Multiple myeloma is a progressive hema­to­logic cancer that originates in the bone mar­row. It is the sec­ond most common blood cancer and remains incurable, with a 5-year sur­vival rate of 44.9%. In 2014, it is esti­mated that approx­i­mately 24,050 new cases will be diag­nosed in the U.S. and more than 11,000 Ameri­cans will die from the dis­ease. Globally, an esti­mated 750,000 people are living with myeloma.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global bio­pharma­ceu­tical com­pany whose mis­sion is to discover, de­vel­op and de­liver inno­va­tive med­i­cines that help patients prevail over serious dis­eases. For more in­­for­ma­tion about Bristol-Myers Squibb, visit www.bms.com, or follow us on Twitter at http://twitter.com/bmsnews.

About AbbVie

AbbVie is a global, re­search-based bio­pharma­ceu­tical com­pany formed in 2013 fol­low­ing separation from Abbott Laboratories. The com­pany’s mis­sion is to use its ex­per­tise, ded­i­cated people and unique ap­proach to inno­va­t to de­vel­op and mar­ket ad­vanced ther­a­pies that address some of the world's most complex and serious dis­eases. AbbVie employs approx­i­mately 25,000 people world­wide and mar­kets med­i­cines in more than 170 countries. For fur­ther in­­for­ma­tion on the com­pany and its people, port­folio and com­mitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Face­book or LinkedIn page.

Bristol-Myers Squibb Forward-Looking State­ments

This press re­lease con­tains "forward-looking state­ments" as that term is defined in the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 re­gard­ing the re­search, devel­op­ment and com­mer­cial­iza­tion of phar­ma­ceut­i­cal prod­ucts. Such for­ward-looking state­ments are based on cur­rent ex­pec­ta­tions and in­volve in­her­ent risks and un­cer­tain­ties, in­­clud­ing factors that could delay, divert or change any of them, and could cause actual out­comes and re­­sults to differ ma­teri­ally from cur­rent ex­pec­ta­tions. No for­ward-looking state­ment can be guar­an­teed. Among other risks, there can be no guar­an­tee that the com­­pounds mentioned in this re­lease will move into full prod­uct devel­op­ment, that the clin­i­cal trials of these com­­pounds will sup­port regu­la­tory filings, or that the com­­pounds will re­ceive regu­la­tory ap­prov­als or, if approved, that they will be­come com­mer­cially suc­cess­ful prod­ucts. Forward-looking state­ments in this press re­lease should be eval­u­ated to­geth­er with the many un­cer­tain­ties that affect Bristol-Myers Squibb's business, par­tic­u­larly those identified in the cautionary factors dis­cus­sion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended De­cem­ber 31, 2013 in our Quar­ter­ly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb under­takes no obli­ga­tion to pub­licly up­date any for­ward-looking state­ment, whether as a re­­sult of new in­­for­ma­tion, future events or other­wise.

AbbVie Forward-Looking State­ments

Some state­ments in this news re­lease may be for­ward-looking state­ments for pur­poses of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995. The words "be­lieve," "expect," "antic­i­pate," "project" and similar ex­pres­sions, among others, generally identify for­ward-looking state­ments. AbbVie cautions that these for­ward-looking state­ments are subject to risks and un­cer­tain­ties that may cause actual re­­sults to differ ma­teri­ally from those in­di­cated in the for­ward-looking state­ments. Such risks and un­cer­tain­ties in­clude, but are not lim­ited to, chal­lenges to in­tel­lec­tual property, com­pe­ti­tion from other prod­ucts, dif­fi­culties in­her­ent in the re­search and devel­op­ment process, adverse lit­i­ga­tion or gov­ern­ment action, and changes to laws and reg­u­la­tions appli­­cable to our industry. Addi­tional in­­for­ma­tion about the economic, competitive, govern­ment­al, tech­no­log­i­cal and other factors that may affect AbbVie's op­er­a­tions is set forth in Item 1A, "Risk Factors," in our 2012 Annual Report on Form 10-K/A, which has been filed with the Se­cu­ri­ties and Ex­change Com­mis­sion. AbbVie under­takes no obli­ga­tion to re­lease pub­licly any revisions to for­ward-looking state­ments as a re­­sult of sub­se­quent events or devel­op­ments, except as re­quired by law.

Source: Bristol-Myers Squibb and AbbVie.